The pilot program demonstrated that AI tools could process large volumes of regulatory data, synthesize documentation, and produce summaries for reviewers, significantly speeding up tasks.

Future enhancements to the AI platform will prioritize improving usability and tailoring outputs to meet the specific needs of different centers.

The FDA has announced plans to expand the use of artificial intelligence (AI) across all its centers by June 30, 2025, following a successful pilot program focused on scientific reviews.

This initiative is part of a broader strategy to modernize the FDA's review processes and enhance public health outcomes through technological advancements.

Jeremy Walsh has been appointed as the FDA's first Chief AI Officer, tasked with overseeing the integration and management of AI technologies within the agency.

Despite the enthusiasm surrounding AI, there are concerns about its credibility and efficiency, which could impact the agency's reputation if not managed carefully.

The initial rollout will be limited but aims to establish a unified, secure generative AI platform across all FDA centers, focusing on document integration and compliance with data security laws.

By alleviating tedious tasks, AI will enable scientists to focus on critical safety evaluations, thereby improving the efficiency of the review process.

AI is expected to help the FDA address delays in the regulatory process, which have increased due to staffing challenges.

The integration of AI marks a significant shift towards practical implementation, potentially transforming how new therapies are evaluated.

Jinzhong Liu, Deputy Director at the FDA, noted that tasks that previously took three days can now be completed in just minutes using AI technology.

The FDA has been in discussions with OpenAI to develop a specialized version of ChatGPT, named cderGPT, to meet its operational needs.